Online Memory Intervention for Individuals With Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT04331392|
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries, Traumatic Brain Injury Traumatic Severe Brain Injury Traumatic Moderate Brain Injury, Chronic||Behavioral: Spatial Navigation Intervention Behavioral: Educational Videos||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomly assigned to either the experimental intervention (allocentric navigation training) or the active control intervention (educational videos).|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Participants are blinded to whether they are completing the experimental or active control intervention.|
|Official Title:||Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: A Randomized Controlled Trial|
|Actual Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||October 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
|Experimental: Spatial navigation intervention||
Behavioral: Spatial Navigation Intervention
The 16-week intervention is completed daily, 5 days/week, remotely from home on a designated study website. Each week participants learn a new city through navigation tasks which increase in difficulty day-to-day and have a total of 4 levels of difficulty, with the goal of being able to independently navigate the city by the end of the week via Google Street View. Participants complete end-of-day multiple-choice tasks, testing what they learned with 3 types of allocentric questions: 1) predicting the next street/landmark, 2) distance judgement and 3) vector mapping. Participants also complete a map placement task, which involves reporting the locations of all studied landmarks/streets.
Participants are presented with auditory rewards in the forms of short audio clips about landmarks, written encouragement in the form pop-ups (e.g., "Good work, keep it up!"), and coffee card rewards based on adherence to the intervention (e.g.,$5 bi-weekly if 100% of intervention is completed).
|Active Comparator: Educational Videos||
Behavioral: Educational Videos
The 16-week active control, remote video intervention is completed daily, 5 days a week by participants on a designated website. Participants placed in the active control group are trained on educational topics by watching videos of Ted Talks, to control for the effects of generalized environmental enrichment of the same dose as targeted navigation training. For each day of training, participants are asked to select between an option of 2 possible videos, watching a total of three videos per day. To ensure compliance and sufficient attention to the videos, at the end of each video, participants are asked to rate 5 aspects of the content (relevance, interest, comprehensibility, complexity, informative), and speaker (persuasiveness, quality of delivery, facial expression, convincingness, captivation), on a scale of 1 (lowest) to 5 (highest). Additionally, as with remote navigation participants, they are given written and monetary rewards.
- Imaging [ Time Frame: Baseline and 1 week post-intervention. ]Efficacy of the intervention will be measured via Magnetic Resonance Imaging (MRI) to observe structural changes to the hippocampi and the integrity of associated white matter from baseline to 1 week post-intervention.
- Change in Cognitive Map Formation Test (CMFT) (Medium transfer) performance, [ Time Frame: Baseline and 1 week post-intervention. ]This assessment measures spatial memory and navigational ability through the formation and flexible use of a mental map of a new environment.
- Change in Route Learning Navigation Test Battery - Different Approach Task (Medium transfer) performance. [ Time Frame: Baseline and 1 week post-intervention. ]This task measures the ability to flexibly shift heading perspective.
- Change in Path Integration Task (Medium transfer) performance. [ Time Frame: Baseline and 1 week post-intervention. ]This task also assesses the ability to flexibly shift heading perspective, as well as path integration through a series of turns initiated by the participant walking through a maze.
- Change in Memory Image Completion Task (MIC) (Far transfer) performance [ Time Frame: Baseline and 1 week post-intervention. ]This task assesses the tendency for pattern completion processes of learned scenes.
- Change in Mnemonic Similarity Test (MST) (Far transfer) performance [ Time Frame: Baseline and 1 week post-intervention. ]This task reflects mnemonic discrimination ability that requires pattern separation by testing memory performance of images of everyday objects
- Navigational abilities (near-transfer) [ Time Frame: Measured throughout the completion of the 16-week spatial navigation intervention. ]To assess improvements to navigation-related, within-task intervention components, the following measures are collected for navigation training patients: 1) spatial learning ability based on end-of-day questions; 2) overall spatial ability improvement based on the difference in performance of end-of-week end-of-day questions, between earlier to later weeks of training; 3) independent navigation ability improvement Streetview-only reverse, alternate, and blocked routes, based on differences in performance between earlier to later weeks of training; and 4) cognitive map formation ability, based on differences in end-of-week performance between earlier and later weeks of training.
- Change in Navigational Strategies Questionnaire score (medium transfer) [ Time Frame: Baseline and 1 week post-intervention. ]Questionnaire measuring self-reported competence in cognitive mapping of routes and large-scale environments, and the formation of survey knowledge based on allocentric or environment-centered frames of reference. Questionnaire contains 14 questions with varying answers. Each response has an answer corresponding to a map-based navigation strategy or characteristic and one corresponding to a non-map/scene-based strategy. The mapping tendency is calculated as the difference between the number of map-based answers and non-map-based answers. Some questions have a third alternative, which is not coded. Final scores range from +14 to -14; the more positive, the more map-based navigation strategies a participant uses which is the better outcome.
- Change in Santa Barbara Sense of Direction Scale score (medium transfer) [ Time Frame: Baseline and 1-week post-intervention. ]Questionnaire measuring self-reported environmental spatial abilities. The responses are measured on a 7-point Likert scale (strongly agree = 1 - strongly disagree = 7), but is reversed for negative-worded questions. The final score is the average of all scores (between 1 and 7) where the higher the score, the better the perceived sense of direction. Increase in score is the better outcome.
- Change in Everyday Memory Questionnaire score (far transfer) [ Time Frame: Baseline and 1 week post-intervention. ]
The test comprises statements regarding forgetting things and patients indicate how frequently the examples have occurred over the prior 3 months. The response options have the following scores: Once or less in the last month=0; More than once a month but less than once a week=1; About once a week=2; More that once a week or less than once a day=3; Once or more in a day=4.
Final score for each participant is obtained by summing up all the scores from individual questions. Final score should range from 0-41, with higher the score, the better the memory. An increase in score is the better outcome.
- Change in Digit Span score [ Time Frame: Baseline and 1-week post-intervention. ]The test measures verbal working memory. Participants are asked to listen to a sequence of numbers and then to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). Each correct response is worth one point; with a maximum of 14 for each subscore series and for the total score, 28. The higher the score, the better verbal working memory. An increase in score is the better outcome.
- Change in Visual Spatial Span score [ Time Frame: Baseline and 1-week post-intervention. ]This task is a behavioral measure of visuospatial working memory capacity. In a sequence, the test administrator taps squares one at a time. The participant must then tap the squares in the same order that they were tapped by the administrator (for the forward variant) or in the reverse order (for backward variant). The number of boxes in the sequence increases from two at the start of the test, to nine at the end and the sequence. Each correct response is worth one point, up to a maximum of 44 points. The higher the score, the better memory. An increase in score is the better outcome.
- Change in Sustained Attention to Response Test (SART) scores [ Time Frame: Baseline and 1-week post-intervention. ]This is a Go/No-Go task measuring attention where participants view a computer monitor on which a random series of single digits are presented at the regular rate of 1 per 1.15 seconds. The task is to press a single response key following each presentation with the exception of a nominated No-Go digit, to which no response should be made. Performance is measured by calculating the number of errors of commission (inappropriately responding to a No-Go stimulus), errors of omission (inappropriately failing to respond to a Go stimulus) and reaction time to Go stimuli. Higher sustained attention should result in fewer errors of commission and omission, with shorter reaction time, which is the better outcome.
- Change in Symbol Digit Modalities Test (SDMT) score [ Time Frame: Baseline and 1-week post-intervention. ]The SDMT is a measure of information processing speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The score is the number of correctly coded items from 0-110 in 90 seconds, the higher the score the better the information processing speed. Higher score is the better outcome.
- Change in the flanker inhibitory control and attention test score [ Time Frame: Baseline and 1-week post-intervention. ]This test measures inhibitory control and selective attention. Participants are required to indicate the left-right orientation of a centrally presented stimulus while inhibiting attention to the potentially incongruent stimuli that surround it (i.e., the flankers, typically two on either side). A composite score of accuracy and reaction time is provided; the greater the score, the better attentional capacity. An increase in this score is the better outcome.
- Change in the dimensional change card sort test score [ Time Frame: Baseline and 1-week post-intervention. ]The test measures executive function. Participants sort a series of bivalent test cards, first according to one dimension (e.g., color), and then according to the other (e.g., shape), A composite score of accuracy and reaction time is provided; the greater the score, the better executive function performance reflecting high accuracy and short reaction time. Increase in score is the better outcome.
- Change in pattern comparison processing speed test score [ Time Frame: Baseline and 1-week post-intervention. ]The test measures information processing speed. Participants are asked to identify whether two visual patterns are the "same" or "not the same" by pressing respective button on the keyboard. Patterns were either identical or varied on one of three dimensions: color, adding/taking something away, or one versus many. Scores reflected the number of correct items (of a possible 130) completed in 90 seconds. The greater the score, the faster the processing speed. Increase in score is the better outcome.
- Change in picture sequence memory test score [ Time Frame: Baseline and 1-week post-intervention. ]The test measures episodic memory. Participant is presented with task stimuli: a sequence of pictured objects and activities related to a central theme (e.g. "working on the farm," "playing at the park,"). Participant must remember the specific order and reproduce it by placing the pictures in the correct temporal order. The score is derived from the cumulative number of adjacent pairs of pictures remembered correctly over the 3 trials. Higher score reflects better performance on task and thereby better episodic memory, which is the better outcome.
- Change in Rey Auditory Verbal Learning Test (RAVLT) performance [ Time Frame: Baseline and 1-week post-intervention. ]RAVLT measures verbal memory. Test administrator reads a list of 15 words at a rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. A number of scores can be derived from the test including Immediate score (the sum of scores from 5 first trials), Learning score (the score of Trial 5 minus the score of Trial 1) and Forgetting score (the score of Trial 5 minus score of the delayed recall). The better outcomes would be increases in Immediate and Learning scores, decrease in Forgetting score.
- Change in Rey Visual Design Learning Test (RVDLT) performance [ Time Frame: Baseline and 1-week post-intervention. ]RVDLT measures memory for nonverbal material. Participants are asked to memorize 15 simple visual items that are presented one by one at a rate of 2 seconds per item. Then, they are asked to draw as many test items as can be remembered. This procedure is repeated four more times. After a 15-20 minutes delay, participants are asked again to draw as many items as possible. In the Recognition phase, a set of 30 visual items containing the test items shown before and 15 items not shown before are presented in random order, participants now have identify the ones shown before in the trials. A number of scores can be derived from the test including free recall score (the sum of scores from 5 first trials), Learning score (the score of Trial 5 minus the score of Trial 1) and Delayed Recall score (the score of Trial 6, after 15-20 minute delay). The better outcome would be an increase in these scores, reflecting an improvement in memory.
- Feasibility: Recruitment rate [ Time Frame: Collected during recruitment ]Determined by dividing the number of patients consented by the number of eligible patients approached. Rate closer to 1 is desired.
- Feasibility: Retention rate [ Time Frame: Collected during recruitment and 1 week post-follow-up ]Determined by dividing the number of consented patients at baseline by the number of consented patients retained at follow-up. Factors influencing retention (e.g., medical status) will be reported as percentages. Rate closer to 1 is desired.
- Feasibility: Compliance rate [ Time Frame: Collected during each of the 80 session (5 sessions/week, 16 weeks) ]
Determined by calculating the percentage of patients adhering to at least 80% of the training protocol. Compliance rates to be computed for individual participants weekly, and for full cohort at end of study. Rate closer to 100% is desired.
Factors influencing recruitment, retention and completion will be documented and reported as percentages.
- Feasibility: semi-structured interview [ Time Frame: 1 week post-intervention ]A semi-structured interview will be administered at post-intervention assessment to ascertain experience with the intervention, and any barriers and facilitation to participation. A qualitative thematic analysis will be applied and key themes will be reported on.
- Change in How Much Is Too Much scale score [ Time Frame: At the end of each of the 16 weeks ]
This scale was developed by our group to quantify a patient's experience of cognitive, somatic and emotional burden in response to completing a cognitive intervention. A list of 26 symptoms will be provided, and the patient will be asked to select whether they have experienced each symptom "Less than before my session today" (=-1); "The same as before my session today" (=0); "I did not have this symptom at all today" (=0); "More than before my session today (=1); "Much more than before my session today" (=2).
By scoring each response according to the number in brackets, and averaging the numbers for all patients per symptom per week, we will evaluate whether participants experienced any particular symptom more often as a result of the intervention across the 16 weeks. Decrease in scores or maintaining a score of 0 week-to-week are the desired outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331392
|Contact: Kadeen Johns, BA||416-597-3422 ext email@example.com|
|Contact: Julia Rybkina, BSc, BA||416-597-3422 ext firstname.lastname@example.org|
|Toronto Rehabilitation Institute||Recruiting|
|Toronto, Ontario, Canada, M5G 2A2|
|Principal Investigator:||Robin E Green, PhD; CPsych||Toronto Rehabilitation Institute|
|Principal Investigator:||Asaf Gilboa, PhD||Baycrest Health Sciences|